In intensive care medicine, difficult decisions

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1 LINEE GUIDA SIAARTI MINERVA ANESTESIOL 2003;69: SIAARTI guidelines for admission to and discharge from Intensive Care Units and for the limitation of treatment in intensive care GRUPPO DI STUDIO AD HOC DELLA COMMISSIONE DI BIOETICA DELLA SIAARTI In intensive care medicine, difficult decisions must constantly be taken concerning the boundary between life and death; it is not unusual for these decisions to be required very rapidly and without the medical staff being in possession of all important information concerning the patient. The guidelines that follow aim to help the intensive care specialist to take decisions concerning the management of patients in intensive care units (ICU). They comprise a bioethical frame of reference, drawn up in a consensual fashion by the Study Group of the same name, originating out of the Bioethical Com-mission of the SIAARTI, to facilitate decision-making processes in intensive care medicine. These guidelines should be considered as general principles rather than specific instructions; for this reason, they consist of a conceptual framework that aims to help in the management of problems in clinical bioethics and not to limit the decision-making power of individual specialists, who remain in possession of the freedom and the related personal responsibility for decisions taken in individual clinical cases. They are consistent with the general ethical principles that regulate care for patients in critical conditions, and that are contained in the following declarations and codes of conduct: the Helsinki Declaration, 1 Ethical Principles in Intensive Care (World Federation of Societies of Intensive and Critical Care MEMBERSHIP OF THE AD-HOC STUDY GROUP. A. Albani, Anaesthetist-rianimation specialist, Biella. C. Barbisan, Bioethics specialist, Treviso Diocese. M. G. Barneschi, Anaesthetist-rianimation specialist, Florence. P. Benciolini, Forensic medicine specialist, Padua University. G. Bertolini, Epidemiologist, Mario Negri Institute, Bergamo. F. Bobbio Pallavicini, Anaesthetist-rianimation specialist, Genoa. A. Braschi, Anaesthetist-rianimation specialist, Pavia University. G. Conti, Anaesthetist-rianimation specialist, Sacro Cuore University, Rome. R. Cecioni, Bioethics specialist, Consulta di Bioetica, Milan. G. Cornara, Anaesthetist-rianimation specialist, Cuneo. C. A. Defanti, Bioethics specialist, neurologist, Niguarda, Milano. E. Facco, Anaesthetist-rianimation specialist, Padua University. A. Giannini, Anaesthetist-rianimation specialist, Clinical Specialization Institutes, Milan. S. Fucci, Magistrate, Court of Milan. F. Giunta, Anaesthetist-rianimation specialist, Pisa University. G. Giurati, Anaesthetist-rianimation specialist, Milan Polyclinic. G. Iapichino, Anaesthetist-rianimation specialist, Milan University. M. Marchesi, Anaesthetist-rianimation specialist, Bergamo. D. Mazzon, Anaesthetist-rianimation specialist, Belluno. P. Moreni, Forensic medicine specialist, Padua University. M. Mori, Bioethics specialist, Turin University. D. Neri, Bioethics specialist, Messina University. L. Orsi, Anaesthetist-rianimation specialist, Crema. R. Proietti, Anaesthetist-rianimation specialist, Sacro Cuore University, Rome. M. Riccio, Anaesthetist-rianimation specialist, Cremona. A. Santosuosso, Magistrate, Court of Milan. M. Scesi, Anaesthetist-rianimation specialist, Chieti University. R. Tufano, Anaesthetist-rianimation specialist, Naples University. F. Turetta, Anaesthetist-rianimation specialist, Mestre. N. Zamperetti, Anaesthetist-rianimation specialist, Vicenza. Received 4 febbraio Accepted for publication 18 febbraio Address reprint requests to: Dr. L. Orsi, U.O. Anestesia e Rianimazione, Ospedale Maggiore, Via Macallè 14, Crema (CR). orsiluciano@tin.it. Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 101

2 Medicine), 2 Medical Code of Conduct ( ), European Convention on Human Rights and Biomedicine 4 and in several consensus statements drawn up by the Ethical Commissions of the most important international scientific societies General rules In ICU, patients who are in a critical condition due to severe instability, actual or potential, of vital functions are monitored and treated. The traditional goals of intensive medicine are: to regain a condition of health; to maintain a dignified life (that is to respect the will of the patient and his or her concept of the quality of life); to relieve pain; to avoid harming the patient; to ensure a dignified death (that is with as little pain as possible and in agreement with the patient s last wishes). The optimal goal of intensive care is the full recovery of the health, so that the patient can re-enter his or her social environment in full. Unfortunately, though, this goal cannot always be achieved and, in some cases, the end result of the disease consists in severe disability or death. In day-to-day clinical practice, the goal that can be concretely set in intensive care medicine may therefore become that of maintaining a dignified life, relieving pain and ensuring a dignified death. In consequence, the fundamental aim of medicine, that is the defence of life, must be tempered in ICU, as in other branches of medicine, by some ethical considerations, in order to avoid descending to mere management of the biological element. In particular, therapy that is disproportionate in the sense of being excessive or that delays death for no advantage should not be practised. The most important aspects of the decision relating to admission to and discharge from ICU and limitation of treatment are: ethical principles; clinical factors (correlated to the patient). Ethical principles In agreement with all international documents, these recommendations are based on the following general ethical principles: autonomy: respect for the patient s selfdetermination; beneficence: to promote the good of the patient; non-maleficence: not to harm the patient (primum non nocere); distribuzione justice: to achieve a fair allocation of limited resources. These general ethical principles apply in the traditional doctor-patient relationship, but are valid and binding also in intensive care medicine. In harmony with the document of the World Federation of Societies of Intensive and Critical Care Medicine, 2 correct evaluation of an ethical problem posed in intensive medicine must be based on verification of the following points: to apply good medical practice with good sense; to apply treatments based on what should (realistically) be done in the specific case and not on all that could (in theory) be done; to respect the following rights of the patient: to receive adequate information about his or her condition and the relative therapeutic options; to obtain the most appropriate therapy among those available; to reject or accept any treatment, including those that support life. In intensive care medicine it is also particularly useful and frequent to apply the criterion of proportionality of treatment. This criterion defines the appropriateness of a treatment on the basis of the following elements: improvement of the quality of life; extension of survival; probability of success and cost to the patient (in terms of pain and suffering) relating to the treatment itself. In particular, the appropriateness of treatment is inversely proportional to the cost to the patient and directly proportional to increase in the quality and quantity of life, as well as to the probability of success. 102 MINERVA ANESTESIOLOGICA Marzo 2003

3 Independence The patient s right to self-determination in regard to health decisions that concern him or her must be respected. This brings with it is the obligation to seek and obtain informed consent for any elective invasive treatment. In emergency conditions it may be impossible to seek and obtain informed consent, due to a condition of incompetence. a However, the patient must, initially or in principle, be considered capable, although his or her clinical condition of severe pain, dyspnea, etc. can potentially impede the expression and achievement of the principle of independence. It is greatly to be hoped that there be a dialogue between medical personnel and the patient (and, if possible, the relatives) in order to make clear the reciprocal health-related goals and to include the patient s will, as expressed directly or indirectly, in the decision-making process. In the phases of the disease prior to the critical condition, the medical staff, in the person of the family doctor or specialist, must encourage the patient to formulate an advance treatment plan so that his or her wishes are respected even when a condition of mental incompetence comes about due to the worsening of clinical conditions. When such a critical condition occurs, the intensive care specialist must take into account the previously-expressed desire. Advance care planning of treatment can take one or more of the following forms of directive: Instruction: directive explicitly formulated by the patient indicating his or her will and desire with regard to present or future pathological conditions, in particular indicating types of treatment that he or she desires to receive or refuse in certain specific clinical situations, especially those predicted with regard to his or her disease (cardiac arrest, permanent vegetative state, dependence on mechanical ventilation, etc.). The directive a ) Mental capability is defined as the patient s capability to understand information relevant to taking decisions, to evaluate the consequence of the choice between treatment and non-treatment, and his or her ability to express the decision in an intelligible fashion. becomes more authoritative if the treatment/non-treatment choices are referred to the patient s formulation of explicit value judgements. b Proxy directive: the patient indicates one or more people (relative, partner, friend, family doctor) in whom he or she has complete trust (the Trustee) and who may represent his or her will in cases of mental incapacity; these Trustees are delegated by the patient to receive information and to participate, together with the medical staff, in the decision-making process concerning therapeutic treatments to be applied or limited. c In general, the medical staff must take into account the will expressed by the patient and the information given by relatives concerning the patient s desires. Opinions of family members that are in contrast with the will expressed by the patient in conditions of mental capability must be accepted and discussed by the medical staff but must not prevail over the patient s will. If the patient is not in possession of his or her faculties, therapeutic decisions must take into account the will previously expressed by the patient or his or her presumed will, thus making reference to 2 traditional ethicaljuridical standards in ethical-clinical decisionmaking: the substitute opinion and the patient s best interests: the substitute opinion, a decisionmaking procedure in which family members and other persons close to the patient are encouraged to express testimony concerning b ) The purpose of advance care planning is not simply to compile a document of therapeutic instructions (a solution in itself more useful to the medical staff than to the patient) but that the patient make explicit his or her convictions and his or her scale of values on which to base treatment choices. This enables such options to be convalidated, when necessary, faced with opposition from 3 rd parties (family members, doctors) and also to reach adequate decisions in the case of particular situations that are not specifically indicated in the document. c ) In the Italian legislation in force, relatives cannot legally replace the patient in giving or withholding consent to health treatment except in the case guardians of persons deprived of civil rights or those exercising parental power. However they can represent an important point of reference in reconstructing the patient s will and can facilitate the decision-making process managed by the medical staff. Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 103

4 the decision the patient would probably have taken in that clinical circumstance; the patient s best interests, a decisionmaking procedure based on the balance between expected benefits and expected costs to the patient of the therapeutic treatment. In Italy as elsewhere, medical staff must, on the basis of legislation in force and codes of conduct, take into account the patient s previously-expressed will in deciding therapeutic treatment. 3, 4 Directives expressed in advance in written or oral form must be held in due consideration, above all if a Trustee can confirm that they correspond to the patient s will. The lack of a Trustee must not in any case compromise a will that was clearly expressed in advance. In very particular situations it is possible not to respect the patient s will; for example, when it is not possible to decide whether the will actually expressed corresponds to his or her presumed long-term will (attempted suicide). The principle of independence in a general way concerns treatments that are indicated from the clinical standpoint; treatment that is not indicated clinically or that appears clearly disproportionate to the patient s condition must not be proposed by the medical staff nor should they be requested to apply it by the patient or his or her representatives (see The ethical clinical decision-making process). All decisions in this sense must be suitably mediated: the medical staff in any case represent the patient s ultimate safeguard and it is their duty to protect him or her from any decision that is against his or her best interests. Beneficence The principle of beneficence refers to the moral obligation to act for the good of others. The good of others includes the prevention of harm or damage, removal of harm or damage, and promotion of good or its achievement. The forms of beneficence thus involve acting to help, to prevent or remove harm, and to achieve good. The highest good for the patient must be achieved in respect of his or her independence. Dialogue with the patient or with his or her relatives may help to define more clearly the principle of beneficence in the right perspective for the patient. For this purpose it is necessary, insofar as it is possible in the intensive care situation, to set up a relationship with the patient and/or his or her relatives in order to improve the decision-making process. Non-maleficence The principle of non-maleficence refers to the moral obligation not to inflict harm or damage to others intentionally. It is generally associated to the traditional maxim Primum non nocere. The principle of non-maleficence entails not intentionally committing actions that cause harm or damage to other persons. Fair distribution of resources The principle of fairness requires that all patients be treated in the same way. Admission and discharge of patients to intensive care and the limits of treatment must not be influenced by age, gender, social value, religious belief, sexual inclinations or wealth. The only criteria to be used in deciding admission of a patient to and discharge from intensive care and limitation of treatment are those of clinical appropriateness (defined by the curability of the disease and the effective utility of intensive care for that patient) and ethical legitimacy (defined by the patient s consent and the respect of the criterion of proportionality). The medical staff who must take decisions concerning admission and discharge to intensive care and limitation of treatment are morally responsible for the fair allocation of the resources assigned to them. This responsibility must not however be considered, in daily clinical practice, as the decisive factor in limiting treatment for individual patients. In case of any conflict between a potentially beneficial treatment for an individual patient and the principle of fair distribution, the medical staff must first safeguard the patient. If the resources available are limited, however, it is ethically justifiable to restrict the use of intensive care on the basis of clinical appropriateness. 104 MINERVA ANESTESIOLOGICA Marzo 2003

5 Clinical factors (correlated to the patient) In the decision-making process, factors linked to the patient must also be taken into consideration since their analysis may improve the quality of the clinical evaluation or clarify the pros and cons of the decision. The main clinical factors to be evaluated are: biological age (paediatric or geriatric patients); personal biography; concomitant diseases; severity and prognosis of the current critical condition; previous and predictable quality of life. Biological age (paediatric or geriatric patients) In a general way, the provision of intensive care should always be evaluated very carefully, above all at the two extremes of life, and thus, in premature or new-born babies, children and elderly persons. Neonatology/paediatrics. In general, admission to ICU is all the more necessary the younger the patient is. However, appropriateness of care must be re-evaluated periodically from the standpoint of the patient s best interests. This is particularly important in new-born and premature infants since they can be maintained in life by intensive care despite extensive brain damage. In paediatric patients and, above all, in new-born and premature babies, evaluation of the predictable quality of life is particularly important and must be taken into account in the decision-making process. In the new-born with serious congenital malformations or perinatal or postnatal damage, prognosis is of special importance. If a child can only survive with artificial life-support, and if it is expected that there will be serious and widespread brain damage, it is ethically legitimate not to initiate or to suspend intensive care, involving parents in the decisionmaking process. In the more controversial cases, a consensus on an adequate diagnostic-therapeutic level may be more easily achieved by asking for the opinion of an ethics consultant and/or the hospital ethical committee. In paediatric patients, the will of parents or guardian must be taken into account in the decision-making process, also in the context of intensive care medicine. This above all in those cases, not infrequent, in which the actual interest of the minor is not easy to define, due to uncertainty in prognosis and when the proposed treatment is especial painful. With paediatric patients who are not yet adult but are capable of evaluating and judging specific situations, their opinion should be taken into account in the decisionmaking process. If the will of parents or guardian does not correspond to that of the paediatric patient, it must be attempted to reach a consensus among all the persons involved in the decision-making process. Geriatrics. In geriatric patients, great importance must be given to the presence of concomitant diseases, to the reduced reserves of vital functions, and to the limited prospects of treatment. Chronological age in itself is not a criterion to decide appropriateness of intensive care, because it is not always correlated with biological age. With geriatric patients in possession of their faculties, the same ethical principles are applied during decision-making processes that are used in younger patients. In geriatric patients with total or partial mental incapacity, the will previously expressed by the patient in the form of a written or oral directive, or of more simple communication of desire and will to friends or relatives, must be taken into account. Evaluation of the clinical appropriateness of intensive care must not in any case be influenced by the negative image that society has of old age. Personal biography The decision-making process must take into account the preferences and values that have characterised the patient s life history. The patient s opinions and feelings about health in the widest sense, physical independence or dependence, pain, the disease, the process of dying and death, as well as his or her future projects, are an important Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 105

6 decision-making basis for the family, friends and health workers. Clear discussion of these elements in advance among patient, relatives, friends and medical staff can greatly facilitate achieving consensus, aid the decision-making process and prevent future conflict among the persons involved. Concomitant diseases It is important in all patients to evaluate concomitant diseases, especially if chronic or degenerative, since these reduce the reserves of vital functions. Very elderly patients suffering from evolving and highly invalidating chronic diseases can rarely be taken into consideration for admittance to intensive care. These considerations hold also, though not above all, for family doctors and other hospital specialists who know the clinical and personal history of their patient in greater detail. These professionals should evaluate beforehand (before the onset of the critical condition) the suitability of requesting intensive care on the basis of an early evaluation of clinical appropriateness and of an advance care plan agreed with the patient and those close to him or her. When valid data become available enabling the early determination of those patients who, though they can survive in intensive care, will not survive to discharge and are therefore in any case destined to die in hospital, these data will have to be taken into careful consideration. Advanced dementia d must be considered as a serious and invalidating concomitant disease that has an unfavourable influence on prognosis. Severity and prognosis of the current critical condition It is ethically appropriate not to admit into ICU patients in whom, with reasonable certainty, it is expected that intensive care will produce no appreciable benefit in terms of d ) Stage of the disease in which the fundamental individual attributes are lost due to the serious deterioration of cognitive functions, leading to the impossibility to actively participate in a therapeutic and rehabilitation program. survival or quality of residual life, or in whom the risks and suffering attached to treatment are greater than the benefits of treatment. In a similar fashion, it is ethically appropriate to limit intensive care when no appreciable benefit can be expected or when the risks and suffering linked to treatment are greater than the benefits deriving from that treatment. Patients in the terminal phase of an irreversible disease must not be treated intensively nor must they be admitted into ICU. Examples of terminal patients who must not receive intensive care are those with devastating cerebral lesions or cerebral lesions not susceptible to treatment or close to brain death who are not organ donors, those suffering from irreversible multi-organ failure, or from cancer that is non-responsive to specific treatment. Patients in a permanent vegetative state, when the prognosis for that patient has been defined by current standards, though not being terminal patients in the strict sense, are patients for whom given the extreme residual invalidity admittance into ICU must be considered as inappropriate and, de facto, counter-indicated (see Previous and predictable quality of life). Moreover, this decision should not be left to the intensive care specialist at the time of emergency, but must be taken in advance by family members and the medical team treating the patient in hospital or at home. Similarly, patients in possession of their faculties who refuse such treatment or request that it be suspended must not be admitted to ICU. Severity scores, designed to compare different patient populations, cannot be used in deciding the appropriateness of intensive care in individual patients. Data deriving from severity scores can provide important but not determinant information for the decisionmaking process in individual cases. The use of today s severity scores as the sole element for evaluating whether to begin or continue intensive care is thus scientifically and ethically incorrect. Previous and predictable quality of life It is ethically justified not to begin or to suspend intensive care when the treatment is 106 MINERVA ANESTESIOLOGICA Marzo 2003

7 disproportionate as excessive, in patients whose quality of life, previous or predictable, is very low, since that treatment would produce more harm than good. The quality of life, previous and predictable, of a patient must be evaluated exclusively from his or her standpoint and not from that of health workers or relatives. Admission to or discharge from ICU Clinical appropriateness of admittance to and discharge from ICU is based on the following elements: 1) reversibility of the acute pathological condition; 2) reasonable probability of expected benefits of intensive care, also in relation to the cost to the patient of the treatment itself; 3) reasonable expectation of resolving the critical condition. Thus intensive care must, in a general way, be reserved for patients with reversible acute diseases or chronic diseases that have reentered an acute phase in which it is reasonable to expect a solution or a good recovery. Logically, organ donors are an exception to this. e Patients, relatives or other persons may therefore not oblige the medical staff to practice intensive care that they believe is clinically inappropriate or counter-indicated. As far as possible in the intensive-care environment, clinical appropriateness should always be evaluated in the light of consent to treatment expressed by the patient after being given adequate information. Admission to ICU Indications to admission to ICU comprise: a current critical condition due to failure of 1 or more vital functions (intensive care) or a high risk of developing a critical state due to the onset of severe and preventable complications; these latter patients therefore require monitoring of vital functions (intensive monitoring). e ) In these patients, despite the condition of brain death, intensive care is clinically and ethically justified until the organs are removed. Patients who require intensive care have priority (due to the presence of a critical condition) over patients who require intensive monitoring, as well as over patients in a critical condition with a worse prognosis. Patients who have no possibility of recovering an acceptable quality of life, as for example patients in a permanent vegetative state, should not be admitted to ICU. Over and above clinical appropriateness (curability of that disease and effective utility of intensive care) admission to and discharge from ICU may be guided by a scale of priorities that classifies patients on the basis of the expected potential benefit of intensive care. The scale is a decreasing one, from priority 1 (maximum expected benefit) to priority 4 (minimal or no expected benefit). Priority 1. Patients in a current critical condition, which can potentially regress with treatment and intensive monitoring that is not possible outside the ICU. These patients are generally not subject to therapeutic limitations. Examples are postoperative failure of vital functions, post-traumatic failure of vital functions or such failure due to a chronic disease entering an acute phase, respiratory or cardio-circulatory failure that requires artificial ventilation, cardio-circulatory, renal, etc. support treatment, as well as invasive monitoring. Priority 2. Patients in a potentially critical condition that requires intensive monitoring and potentially needs immediate invasive treatment. In general no therapeutic limitations are set in these patients. These patients are, for example, those with chronic diseases that have re-entered an acute phase due to medical or surgical complications. Priority 3. Patients in a critical condition due to an acute disease in which the response to intensive care remains to be defined, and in some cases therapeutic limits must be set relating to complex and invasive treatment (for example, mechanical ventilation, cardio-pulmonary reanimation, cardio-circulatory support, hemodyalisis, etc.). This level of priority includes very elderly patients as well as, for example, patients with complicated neoplastic disease and patients with chronic advanced parenchymal failure. Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 107

8 Priority 4. Patients for whom admission to intensive care is not appropriate excepting in some individual cases for particular circumstances. These patients may be subdivided into the following 3 categories: Non-severe clinical condition such that admission to ICU would offer little or no benefit. These patients are in a condition that is not sufficiently severe to benefit from intensive care, and may be treated and/or monitored in other wards. Examples of these clinical conditions are: mild to moderate cardiorespiratory failure, pharmacological intoxication with mild cerebral failure, mild cranial trauma, etc. Terminal phase of irreversible diseases in which death is imminent, or deterioration of very advanced chronic diseases with severe disability. These patients are in a clinical condition that is too severe to benefit from intensive care and can be cared for in other wards or at home. Examples of these clinical situations are: extensive untreatable cerebral lesions, conditions close to brain death where organ donation is not planned, f irreversible multi-organ failure, advanced cancer not responding to specific treatment, permanent vegetative state, etc. Refusal of intensive care by competent patients. It is imperative to respect this therapeutic refusal in all cases in which prognosis is in any case doubtful or can reasonably be expected to be negative, and the efficacy of the proposed treatment is not certain. It should also be taken into very serious consideration when the therapeutic approach appears to offer a reasonable possibility of success, above all if formulated in advance and based on a scale of values and a view of life that are clearly expressed by the patient. In doubtful cases, family members and spouses can offer valid support to define the authentic will of the patient; this not to limit the right of the patient to self-determination but to decide more accurately a therapeutic approach that respects the patient s value scale. In cases in which a patient in conditions f ) If organs are not to be removed, the condition of brain death removes every other clinical and ethical justification to maintain life support. covered by priorities 1, 2 or 3 cannot be accommodated in ICU due to lack of beds, it is necessary to search for a bed available at another ICU and meanwhile to ensure the most appropriate care. When the possibility of achieving the therapeutic goal is uncertain or the will of the patient is not known, if it is preferable to decide to initiate intensive care for the purpose of evaluating clinical response and gaining time to obtain the necessary information. After a certain period of treatment the clinical situation will be re-evaluated and the treatment may be limited if it has become clear that there is no response to treatment or that the patient s will is to the contrary. In brief, as long as there is reasonable doubt or uncertainty concerning the irreversibility of clinical conditions it is appropriate to begin or continue intensive care. Vice versa, if there is reasonable certainty on the irreversibility of the clinical situation, it is appropriate not to begin or to interrupt intensive care in order not to unduly prolong the process of dying. Discharge from ICU The criteria to be adopted in discharging patients from ICU must be similar to those followed in deciding admission. The clinical condition of patients in ICU must be periodically re-evaluated to determine which patients no longer require intensive care or monitoring. In brief, discharge from ICU is based on the following criteria: A) Intensive monitoring or treatment is no longer needed due to the resolution of the critical condition and improvement of the disease that was responsible for admission. B) Intensive monitoring or treatment should be suspended as having become inappropriate as excessive due to the irreversibility of the clinical situation and the lack of response to treatment. C) Explicit retraction by the patient of previously expressed consent; or a therapeutic limit that was agreed previously is reached. 108 MINERVA ANESTESIOLOGICA Marzo 2003

9 Forgoing of treatment Every patient admitted to ICU must receive an appropriate level of care. It is perfectly appropriate to set limits to treatment if it becomes evident with the passage of time that pursuing such treatment is not leading to a favourable result and is prolonging the process of dying, involving additional suffering for the patient. When continuance of treatment amounts to doggedly seeking partial results without any effective utility in terms of prognosis and quality of survival for the patient, this constitutes treatment inappropriate as excessive (commonly known as therapeutic obstinacy g ). Overtreatment is ethically deplorable and unanimously condemned since it amounts to an inappropriate utilisation of treatment resources, it is needlessly painful for the patient, causing physical and psychic harm, and does not respect the dignity of dying. Overtreatment is also morally illegitimate since it increases the suffering of family members, is frustrating for the medical staff and produces an unfair distribution of resources, making them unavailable to other patients. Respect for the sanctity of life need not be pushed to the extreme limit of idolatry of the body; thus the medical staff are not morally obliged to initiate or continue treatment that maintains a mere biological life and prolongs the process of dying. Intensive care should be begun or continued only when there is a reasonable probability of success with a result that is acceptable to the patient. Treatments that are inappropriate as excessive are susceptible to limitation in the sense either of with holding or of with drawing. Limitation of treatment evaluated as being inappropriate must come about after a careful evaluation of all clinical and ethical factors and be undertaken together with the patient if mentally capable or his or her family members. In the case of unfavourable prognosis, lifesupport treatment must be limited including on the basis of the expressed or presumed g ) We prefer the definition inappropriate treatment for excess to that of therapeutic obstinacy because it has no negative moral connotations and makes more correct reference to criteria of clinical and ethical appropriateness. will of the patient, since continuation of such treatment would involve an extension of the process of dying against the patient s will and that is harmful to his or her dignity. The forgoing of life-support treatment has the sole purpose of not extending the process of dying, enabling the patient to die from his or her disease; it is therefore not an act of euthanasia, i.e. the intentional suppression of human life. On the contrary, in the terminal phases of the disease, it is clinically appropriate and ethically dutiful not to prolong the process of dying. h When therapeutic limitations are held to the appropriate, this should be practised in such a way as not to generate suffering or discomfort for the patient (in particular, providing an adequate level of sedation). In any case, the patient is ensured adequate care and, insofar as it is possible, the presence of family members. That decision to suspend or limit certain types life-support is compatible with maintaining other treatment that, for each individual patient, may appear to be accepted and indicated to reduce psycho-physical suffering (see Palliative care). From the ethical standpoint, there is a consensus in denying any moral difference between not beginning treatment (with holding) and suspending treatment (with drawing); thus abstention from and suspension of treatment are to be considered ethically equivalent. 2 In this sense, with drawing of intensive care that had previously been begun because it was indicated and accepted, or because at that point in time the clinical condition and related prognosis had not been defined in sufficient clarity, should be taken into consideration whenever the clinical situation counter-indicates its continuance, whenever the patient s consent is retracted or a previously defined therapeutic limit is reached. h ) Limitation of treatment that is no longer clinically indicated is not intended to bring about the patient s death; it is on the contrary the obvious consequence of the recognition of the uselessness of these treatments and of their incapability of effectively changing the prognosis and/or quality of life for that patient, together with the will to respect his or her life to the end, avoiding any excess of needless or non-respectful treatment. Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 109

10 The ethical-clinical decision-making process In a general way, medical staff are not morally obliged to offer, initiate or continue treatment that they evaluate as being inappropriate due to the impossibility of reaching the relative clinical goals. When there is consensus among the doctors in charge of the case concerning the inappropriateness of treatment, it is possible to proceed to forgoing such treatment. In determining the ethical appropriateness of treatment, due consideration must be given to the patient s desires and opinions concerning the quality of his or her life. In the absence of reliable information concerning the patient s desires and opinions, information provided by the family or other persons close to the patient must be taken into account. If the evaluation of the medical staff on the question of limiting treatment diverges from that of a mentally capable patient or from that of family members of an incapable patient, it is recommended to try to reach consensus among all the parties involved. In cases of limitation of treatment of an incapable patient, if possible all the health workers involved in clinical management should be brought into the decision-making process so as to obtain a more complete evaluation, and to allow each of them the opportunity to express their opinions. It is important to make every possible effort to reach consensus among all the professionals involved concerning the suitability of limiting treatment in individual clinical cases. After an in-depth illustration of the clinical situation, opinions of family members must be taken into consideration. Responsibility for limiting treatment must not however be transferred to the family but must remain in the hands of the medical staff. The decision-making process should be entered into the clinical record. i i ) During the decision-making process it is advisable to enter details of the process of achieving consent into the clinical record, following a formula that includes these elements: principal characteristics of the clinical situation, reasons for therapeutic limitation, names of family members and health workers who have directly participated in the decision-making process. In cases of disagreement on the suitability of limiting treatment between medical staff and the patient or family, or within the medical team, every effort should be made to attempt to achieve consensus. The phases recommended to resolve a disagreement are, in order of precedence, as follows: attempt to overcome the difference of opinion by improving the quality of relations and communication; this may involve reviewing information previously provided in search of misunderstandings or errors, as well as greater participation in the decision-making process of the patient if capable, family members, other health workers or other supporting professionals (psychologist, church minister, etc.); seek help from other institutional departments (ethics committee, ethical consultant, etc.). l Palliative care In putting in place limitations on treatment, health workers must not abandon the patient and must constantly alleviate his or her suffering. In forgoing treatments, it is obligatory to continue palliative care, even though this may involve an acceleration of the process of dying. In particular, it is a unanimously agreed ethical duty to practice optimal therapy to relieve pain and other forms of suffering that accompany this process, even if this may bring forward the actual moment of death. Thus, having taken the decision to limit treatment, the patient remains in the charge of the medical staff who manage his or her care until death, or arrange for transfer to another structure or the patient s home. The patient and his or her family continue to have the right to receive the necessary attention and due respect. l ) The ethics committee and the ethical consultant, though having no deliberative role but only a consultative role, can be of help in correctly framing the ethics of the problem and can facilitate the decision-making process. 110 MINERVA ANESTESIOLOGICA Marzo 2003

11 References 1. World Medical Association declaration of Helsinki. Recommendations guiding medical doctors in biomedical research involving human subjects. JAMA 1997;277: The World Federation of Society of Intensive and Critical Care Medicine. Ethical Principles in Intensive Crit Care Digest 1992;11: Codice di Deontologia Medica (Approvato da Comitato Centrale della FNOMCeO il ). 4. Consiglio Europeo. Convenzione sui diritti umani e la biomedicina. Oviedo, 4 aprile 1997; ratificata dal Parlamento Italiano, 14 marzo Recommendations for intensive care unit admission and discharge criteria. Task Force on Guidelines. Society of Critical Care Medicine. Crit Care Med 1988;16: Ethical and moral guidelines for initiation, continuation, and withdrawal of intensive care. American College of Chest Physicians/Society of Critical Care Medicine Consensus Panel. Chest 1990;97: Guidelines for utilisation of intensive care units. European Society of Intensive Care Medicine. Intensive Care Med 1994;20: Consensus statement on the triage of critically ill patients. Society of Intensive Care Medicine. JAMA 1994;271: Nasraway SA, Cohen IL, Dennis RC, Howenstein MA, Nikas DK, Warren J et al. Guidelines on admission and discharge for adult intermediate care units. American College of Critical Care Medicine of Society of Critical Care Medicine. Crit Care Med 1998;26: Guidelines for intensive care units care admission and discharge, and triage. Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med 1999;27: Guidelines for developing admission and discharge policies for pediatric intensive care unit. Pediatric Section Task Force on Admission and Discharge Criteria, Society of Critical Care Medicine in conjunction with the American College of Critical Care Medicine and the Committee on Hospital of the American Academy of Pediatrics. Crit Care Med 1999;27:4: Central Ethics Committee of Swiss Academy of Medical Sciences, Medical-ethical guidelines on borderline questions in intensive-care medicine. Schewiez Med Wochenschr 1999;129: Consensus statement of the Society of Critical Care Medicine s Ethics Committee regarding futile and other possibly inadvisable treatments. Crit Care Med 1997;25: Medical-ethical guidelines for the Medical Care of Dying or Severly Brain-damage Patients. Schweiz Artzeitung 1995;76: Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M et al. Recommendation for end-of-life in the intensive care unit: The Ethics Committee of the Society of Critical Care. Crit Care Med 2001;29: Raccomandazioni SIAARTI per l ammissione e la dimissione dalla terapia intensiva e per la limitazione dei trattamenti in terapia intensiva Nella medicina intensiva si devono costantemente prendere difficili decisioni sulla linea di confine fra la vita e la morte. Non raramente queste decisioni devono essere assunte in tempi rapidi e senza disporre di tutte le informazioni importanti riguardanti il paziente. Le seguenti raccomandazioni hanno lo scopo di aiutare gli intensivisti a prendere decisioni che riguardano la gestione dei pazienti in Terapia Intensiva (TI). Esse rappresentano uno schema di riferimento bioetico, stilato in modo consensuale dall omonimo Gruppo di studio sorto dalla Commissione di Bioetica della SIAARTI, per facilitare il processo decisionale nella medicina intensiva. Queste raccomandazioni devono essere considerate come principi generali e non come specifiche istruzioni. Pertanto, rappresentano una cornice concettuale intesa a favorire la gestione dei problemi di bioetica clinica e non a limitare la potestà decisionale del singolo intensivista, il quale mantiene la libertà e la correlata responsabilità personale nelle decisioni adottate nei singoli casi clinici. Esse sono coerenti con i principi etici generali che regolano la cura dei pazienti in condizioni critiche e che sono riportati nelle seguenti dichiarazioni e codici deontologici: Dichiarazione di Helsinki 1, Ethical Principles in Intensive Care (World Federation of Society of Intensive and Critical Care Medicine) 2, Codice di Deontologia Medica ( ) 3, Convenzione Europea di Oviedo sui Diritti Umani e la Biomedicina 4, oltre che nei numerosi documenti di consenso stilati dalle Commissioni Etiche delle principali società scientifiche internazionali Regole generali Nei reparti di TI si effettuano il monitoraggio e il trattamento di pazienti che sono in condizioni critiche a causa di una grave instabilità, in atto o potenziale, delle funzioni vitali. I tradizionali obiettivi della medicina intensiva sono: recuperare lo stato di salute; mantenere una vita dignitosa (ossia rispettosa delle volontà del paziente e del suo concetto di qualità della vita); controllare la sofferenza; evitare danni al paziente; Vol. 69, N. 3 MINERVA ANESTESIOLOGICA 111

12 garantire una morte dignitosa (ossia con il minor grado di sofferenza ed in accordo con i desideri ultimi del paziente). L obiettivo ottimale del trattamento intensivo è il recupero totale dello stato di salute per permettere un completo reinserimento del paziente nel suo ambiente sociale. Purtroppo però questo obiettivo non può essere raggiunto in tutti i pazienti e, in alcuni casi, l esito finale della malattia è rappresentato da una grave disabilità o dalla morte. Nella pratica clinica quotidiana l obiettivo concretamente perseguibile dalla medicina intensiva può diventare, pertanto, quello del mantenimento di una vita dignitosa, del controllo della sofferenza e della garanzia di una morte dignitosa. Conseguentemente, l obiettivo fondamentale della medicina, ossia la difesa della vita, per non scadere a gestione del mero dato biologico, deve essere temperato, in TI come in altre branche della medicina, da alcune considerazioni etiche. In particolare, non devono essere praticate quelle terapie sproporzionate per eccesso che procrastinano inutilmente la morte. Gli aspetti più importanti delle decisioni relative al ricovero, alla dimissione dei pazienti dalla TI e alla limitazione dei trattamenti, sono: i principi etici; i fattori clinici (correlati al paziente). I principi etici In sintonia con tutti i documenti internazionali, queste raccomandazioni si fondano sui seguenti principi etici generali: autonomia: rispetto per l autodeterminazione del paziente; beneficialità: promuovere il bene per il paziente; non maleficialità: non fare il male del paziente (primum non nocere); giustizia distributiva: realizzare un equa allocazione delle risorse scarse. Questi principi etici generali si applicano nella tradizionale relazione medico-paziente, ma risultano validi e vincolanti anche nella medicina intensiva. In sintonia con il documento della World Federation of Society of Intensive and Critical Care Medicine 2, una corretta valutazione di un problema etico insorto nella medicina intensiva, dovrebbe fondarsi sulla verifica dei seguenti elementi: l esercizio di una buona pratica medica condotta con buon senso; l effettuazione di trattamenti basati su ciò che dovrebbe (realisticamente) essere fatto nel caso specifico e non su tutto ciò che potrebbe (teoricamente) essere fatto; il rispetto dei seguenti diritti del paziente: ricevere un adeguata informazione circa le proprie condizioni e le relative opzioni terapeutiche; ottenere la terapia più appropriata tra quelle disponibili; rifiutare o accettare qualsiasi trattamento, compresi quelli di sostegno vitale. Nella medicina intensiva è inoltre particolarmente utile e frequente ricorrere al criterio della proporzionalità delle cure. Questo criterio definisce l appropriatezza di un trattamento in base ai seguenti elementi: miglioramento della qualità di vita, prolungamento della sopravvivenza, probabilità di successo e oneri (in termini di disagi e sofferenze) relativi al trattamento stesso. In particolare, l appropriatezza di un trattamento risulta inversamente proporzionale agli oneri e direttamente proporzionale all incremento della qualità e quantità di vita, oltre che alle probabilità di successo. Autonomia Il diritto del paziente di autodeterminarsi in merito alle scelte sanitarie che lo riguardano deve essere rispettato. Ciò comporta l obbligo di ricercare e ottenere il consenso informato per ogni trattamento invasivo d elezione. In condizioni di urgenza può risultare impossibile ricercare e ottenere il consenso informato a causa dello stato di incapacità mentale a. Comunque, il paziente deve, per principio, essere considerato capace, anche se le condizioni cliniche di grave dolore, dispnea, ecc., possono potenzialmente inficiare l espressione e la realizzazione del principio di autonomia. È fortemente auspicato un dialogo tra i sanitari e il paziente (e, se possibile, i parenti) al fine di esplicitare i reciproci obiettivi di salute e di includere le volontà, direttamente o indirettamente espresse dal paziente, nel processo decisionale. Nelle fasi di malattia precedenti lo stato critico i curanti, in ambito domiciliare o specialistico, devono incoraggiare il paziente a formulare una pianificazione anticipata delle cure per fare in modo che le sue volontà siano rispettate anche qualora subentri uno stato di incapacità mentale per l aggravarsi delle condizioni cliniche. Al verificarsi dello stato critico l intensivista deve tener conto di tali volontà precedentemente espresse. La pianificazione anticipata delle cure può assumere una o più delle seguenti forme: Direttiva di istruzione: formulazione esplicita da parte paziente delle sue volontà e dei suoi desideri in relazione a stati patologici presenti o futuri, con indicazione in particolare dei tipi di trattamento che egli desidera ricevere o rifiutare in alcune situazioni cliniche specifiche, specie quelle prevedibili in relazione alla sua patologia (arresto cardiaco, stato vegetativo permanente, dipendenza dalla ventilazione meccanica, ecc.); tutto ciò assume una maggiore autorevolezza se le scelte di trattamento o di non a ) La capacità mentale è definita dalla possibilità per il paziente di capire le informazioni rilevanti all assunzione di decisioni, di valutare le conseguenze delle scelte di trattamento o di non trattamento e dall espressione in modo intelligibile delle relative scelte decisionali. 112 MINERVA ANESTESIOLOGICA Marzo 2003